Luna Innovations Submits FDA 510(k) Application for EDAC(TM) QUANTIFIER Monitor
03 Maio 2007 - 10:52AM
Business Wire
Luna Innovations (NASDAQ: LUNA) announced today that it has
submitted its 510(k) application to the U.S. Food and Drug
Administration for the EDACďż˝ (Emboli Detection and Classification)
QUANTIFIER. This innovative medical device uses quantitative
ultrasound technology to non-invasively count and measure gaseous
emboli in the extracorporeal blood circuits. FDA clearance would
enable Luna Innovations to market and sell the EDAC QUANTIFIER for
clinical use in the United States. The EDAC QUANTIFIER represents a
breakthrough in cardiothoracic surgery. The instrument is designed
to reliably detect harmful gaseous emboli during open-heart
surgery. Gaseous emboli are air bubbles that may enter or are
created in the blood circuit during critical and invasive medical
procedures such as cardio- pulmonary bypass surgery. The EDACďż˝
QUANTIFIER can provide the surgical team with data on the quantity
and volume of gaseous emboli at multiple locations in
extracorporeal circuits during a procedure. David Blaker, Vice
President of Medical Products, commented, �The FDA submission
represents a significant milestone and growth opportunity for Luna
Innovations. Research studies acknowledge the relationship between
an increased number of emboli delivered to the brain and an
increase in the number of neurological or neurocognitive deficits
in patients after surgery. Using innovative and sophisticated
technology, coupled with noninvasive monitoring techniques, the
EDAC QUANTIFIER exemplifies Luna�s commitment to providing medical
instruments that will improve the quality of patient care.ďż˝ In a
related announcement, Luna Innovations has hired Brian Murach as
its Director of North American Medical Products Sales. Murach has
extensive clinical experience as a Certified Physician Assistant
and more than 16 years experience in medical equipment sales. He is
the former National Sales Manager for Terumo Cardiovascular
Systems, and has held the positions of Regional Sales Manager with
Spencer Technologies, and National Sales Manager with Neuroscan
Medical Systems/DWL Systems. ABOUT LUNA INNOVATIONS: Luna
Innovations Incorporated develops and manufactures new-generation
products for the healthcare, telecommunications, energy and defense
markets. Our products are used to measure, monitor, protect and
improve critical processes in the markets we serve. Through its
disciplined commercialization business model, Luna has become a
recognized leader in transitioning science to solutions. Luna is
headquartered in Roanoke, Virginia. Additional information can be
found at www.lunainnovations.com. FORWARD LOOKING STATEMENTS This
press release includes information that constitutes
�forward-looking statements� made pursuant to the safe harbor
provision of the Private Securities Litigation Reform Act of 1995,
including but not limited to the statement that FDA clearance would
enable the company to market and sell the EDAC QUANTIFIER for
clinical use. Statements that describe the Company�s business
strategy, goals, objectives, prospects, opportunities, plans or
intentions are also forward-looking statements. Actual events or
results may differ materially from the expectations expressed in
such forward-looking statements as a result of various factors,
including risks and uncertainties, many of which are beyond the
Company�s control. Factors that may affect the future results of
Luna Innovations are set forth in its Annual Report on Form 10K,
its periodic reports on Forms 10-Q and other filings with the
Securities and Exchange Commission (�SEC�). These things are
available at the SEC�s website at http://www.sec.gov and at Luna
Innovationsďż˝ website at http://www.lunainnovations.com. The
statements made in this press release are based on information
available to the company as of the date of this release and Luna
Innovations undertakes no obligation to update any of the
forward-looking statements herein after the date of this press
release.
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